Siemens Atellica CH Revised C Reactive Protein Assay Software Flagging Issue
Siemens Healthcare Diagnostics is recalling the Atellica CH Revised C Reactive Protein assay due to incorrect software flagging that may produce erroneous results.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall. No illnesses or injuries are reported in the source text, and the hazard is identified as a software issue that "may potentially" lead to erroneous results. The theoretical nature of the harm and absence of reported adverse events places this in the Moderate category.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling the Atellica CH Revised C Reactive Protein (RCRP), Siemens Material Number (SMN) 11537223, due to a software issue that may cause incorrect flagging of assay results.
The assay may produce erroneous results due to incorrect software flagging. This issue affects all lots of the product distributed nationwide in the United States and internationally across multiple countries including Australia, Austria, Brazil, Canada, China, France, Germany, India, Israel, Italy, Japan, Korea, Netherlands, New Zealand, Singapore, Spain, Sweden, Switzerland, Taiwan, United Kingdom, and many others.
Healthcare providers and laboratories using this product should contact Siemens Healthcare Diagnostics, Inc. for guidance on addressing this issue and any necessary corrective actions or replacement products.
The recalled product
- Product
- Atellica CH Revised C Reactive Protein (RCRP); Siemens Material Number (SMN): 11537223.
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Siemens Material Number (SMN): 11537223
- UDI-DI: 00630414610887
- Lot numbers: All lots.
Distribution
Distributed nationwide across the United States.
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